Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach

NCT04662333 | Unknown DMC

• 1 other identifier: CLS001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Patients in need for implant-supported restoration in maxillary posterior sites with insufficient residual bone height will be randomly allocated to two different arms. Crestal sinus lift with simultaneous implant placement will be performed in both groups. Control group: crestal sinus lift with no adjunctive biomaterial; Test group: crestal sinus lift associated with xenogenic bone graft and collagen membrane; Six months after implant placement, implants will be loaded with definitive screw-retained prostheses. Six months later, patients will be recalled for clinical and radiographic assessment.

Conditions

Edentulous Jaw

Keywords

Dental implant; Sinus lift; maxillary atrophy; biomaterials

Outcome Measures

Primary Outcomes (1)

• Complications rate

  amount of complications assessed at patient level

  12 months

Secondary Outcomes (3)

• Peri-implant bone stability

  12 months

• Implant stability quotient

  baseline, 1 month, 3 months, 6 months

• Soft tissue inflammation

  6 months

Study Arms (2)

Crestal sinus lift

ACTIVE COMPARATOR

Implant site preparation with detachment of Schneiderian membrane and subsequent implant placement. The corresponding healing abutment is made up of PEEK (poly-ether-ether-ketone)

Procedure: Transcrestal approach for sinus lift

Crestal sinus lift with adjunctive xenograft

EXPERIMENTAL

Implant site preparation with detachment of Schneiderian membrane. After that, collagen membrane plus xenogenic bone substitute will be placed into the site before implant placement. The corresponding healing abutment is made up of titanium.

Procedure: Transcrestal approach for sinus lift; Procedure: Xenograft application

Interventions

Transcrestal approach for sinus lift PROCEDURE

After surgical exposure of maxillary alveolar crest, implant site preparation and transcrestal detachment of Schneiderian's membrane will be performed. Thereafter implant will be placed, protruding in the maxillary sinus with its apical part.

Crestal sinus lift; Crestal sinus lift with adjunctive xenograft

Xenograft application PROCEDURE

Before implant placement, xenogenic collagen membrane and bone granules will be pushed under the Schneiderian's membrane through the surgical site.

Crestal sinus lift with adjunctive xenograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• more than 18 years old
• edentulous in posterior maxilla
• patient in need of sinus augmentation procedure
• residual bone height greater than 3mm

You may not qualify if:

• systemic chronic diseases affecting osseointegration
• contraindication for implant therapy
• less than 18 years
• uncontrolled periodontitis
• smoker (more than 10 cig/day)

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

AOUS

Siena, 53100, Italy

RECRUITING

MeSH Terms

Conditions

Jaw, Edentulous; Atrophic Maxilla

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases; Bone Resorption; Bone Diseases; Maxillary Diseases

Central Study Contacts

Nicola D Discepoli, Professor

CONTACT

3392491188; ndiscepoli@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 29, 2020
• First Posted: December 10, 2020
• Study Start: October 1, 2020
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: December 10, 2020

Record last verified: 2020-12

Locations

IT (1)